Important Safety Information
The device output is not a clinical diagnosis. The probability distributions, severity scores, and clinical sign quantifications produced by the device are clinical decision support information that must be interpreted by a qualified healthcare professional in the context of the patient's complete clinical picture.
The device should never be used to confirm a clinical diagnosis. Its output is one element of the overall clinical assessment. The healthcare professional retains full diagnostic authority and independent clinical judgment in all use cases.
Understanding the device output
The device produces probabilistic outputs — a ranked list of possible conditions with associated probability scores — rather than a definitive diagnostic conclusion. This is a fundamental characteristic of its operation:
- The device cannot confirm the presence of a condition. The output is always a probability distribution across ICD categories, never a binary "positive" or "negative" result.
- The probability distribution may be concentrated or dispersed across categories, but it always represents a range of possibilities, not a single conclusion.
- Severity scores and clinical sign quantifications are objective measurements intended to support clinical assessment, not to replace it.
Population and performance variability
The device was validated using clinical datasets spanning diverse clinical presentations and Fitzpatrick skin phototypes (I through IV). Performance may vary across demographic subgroups, including skin phototypes, age groups, and geographic populations not proportionally represented in the validation datasets. Healthcare professionals should exercise particular clinical judgment when:
- Assessing patients with skin phototypes (V and VI) that may have limited representation in the training and validation data.
- Evaluating conditions in paediatric or geriatric patients, where presentation patterns may differ from the adult populations that constitute the majority of the validation data.
- Working in geographic regions or clinical settings with condition prevalence patterns that differ from those in the validation studies.
The device output should always be interpreted in the context of the patient's individual clinical presentation. Performance variability across subgroups does not affect the device's safety profile because the healthcare professional retains full diagnostic authority in all cases.
When to use the device
The device is designed to be used when a healthcare professional chooses to obtain additional information to support a clinical decision. The healthcare professional combines their clinical knowledge, the patient's medical history, physical examination findings, laboratory results, and the device output to reach a diagnostic and therapeutic decision.